CMC/MANUFACTURING definition

CMC/MANUFACTURING means the development of one or more processes for the manufacture and packaging of the Antibody and/or the Product for Preclinical Development, Clinical Development and Commercialization, and shall include, without limitation, formulation, production, fill/finish, sourcing of components, raw materials and packaging supplies, development of regulatory methods and controls, including assays, quality control and quality assurance methodology and stability protocols, qualification of one or more Antibody production facilities and one or more radiolabeling facilities.
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CMC/MANUFACTURING means the development of one or more processes for the manufacture and packaging of the Compound and / or the Product for Preclinical Development, Clinical Development and Commercialization, and shall include, without limitation, formulation, production, fill / finish, sourcing of components, raw materials and packaging supplies, development of regulatory methods and controls, including assays, quality control and quality assurance methodology and stability protocols, and qualification of one or more Compound and Product production facilities.
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CMC/MANUFACTURING means, as applicable for a particular Collaboration Product, CMC Step 2 or CMC Step 4. “CMC Manufacture” shall have a correlative meaning.
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More Definitions of CMC/MANUFACTURING

CMC/MANUFACTURING means the development of one or more processes for the manufacture and packaging of the Product for Preclinical Development, Clinical Development and Commercialization, and shall include, without limitation, formulation, production, fill/finish, sourcing of components, raw materials and packaging supplies, development of regulatory methods and controls, including assays, quality control and quality assurance methodology and stability protocols.
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CMC/MANUFACTURING means the development of one or more processes for the manufacture and packaging of the Product for Preclinical Development, Clinical Development and Commercialization necessary to achieve a scale of [*] per aggregate batch, defined as the sum of the batch size capacities of development facilities. This includes, without limitation, formulation, production, fill-finish, sourcing of plant, equipment, components, raw materials and packaging supplies, development of regulatory methods and controls, including assays, quality control and quality assurance methodology and stability protocols, and qualification and scale-up of one or more production facilities.
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CMC/MANUFACTURING means the development of one or more processes for the manufacture and packaging of the Product for Preclinical Development, Clinical
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CMC/MANUFACTURING means the development of one or more processes for the manufacture and packaging of the Antibody and/or the Product for Preclinical Development, Clinical Development and Commercialization, and shall include, without limitation, formulation, production, fill/finish, sourcing of components, raw materials and packaging supplies, development of
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Related to CMC/MANUFACTURING

  • Remanufacturing means the activity of overhauling, retrofitting, fabricating, or repairing a product or its component parts for ultimate sale at retail.

  • Manufacturing means all activities directed to sourcing of necessary raw materials, producing, processing, packaging, labeling, quality assurance testing, release of a Licensed Product or Licensed Product candidate, whether for Development or Commercialization. When used as a verb, “Manufacture” means to engage in Manufacturing.

  • Manufacturing Process means any process for—

  • Manufacturing Technology means any and all patents, patent applications, Know-How, and all intellectual property rights associated therewith, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno- associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • Brewery manufacturing license means a license issued in accordance with